Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid

K222294 · Onetexx Sdn Bhd · LZA · Sep 24, 2022 · General Hospital

Device Facts

• Record ID: K222294
• Device Name: Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
• Applicant: Onetexx Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Sep 24, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This Nitrile patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner, and has also been Tested for Use with the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid.

Device Story

Disposable nitrile patient examination glove; worn on hands/fingers by healthcare personnel; provides barrier protection against cross-contamination. Tested for permeation resistance against specific chemotherapy drugs and opioids (Fentanyl citrate) in simulated gastric acid environments per ASTM D6978-05 (2019). Used in clinical settings; non-sterile. Output is physical barrier protection; informs clinical decision-making regarding appropriate personal protective equipment (PPE) selection during handling of hazardous drugs or opioids.

Clinical Evidence

Bench testing only. Permeation testing performed per ASTM D6978-05 (2019) to determine breakthrough times for 14 chemotherapy drugs and Fentanyl citrate/gastric acid mixtures. Results show breakthrough times ranging from 32.5 minutes (Carmustine) to >240 minutes for most substances.

Technological Characteristics

Nitrile rubber material; non-sterile; powder-free; disposable. Permeation resistance tested per ASTM D6978-05 (2019).

Indications for Use

Indicated for use as a disposable patient examination glove worn by healthcare personnel to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs, Fentanyl citrate, simulated gastric acid, and Fentanyl in gastric acid.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

September 24, 2022

Onetexx SDN BHD % Wava Truscott President Truscott MedSci Associates, LLC 180 Burkemeade Ct. Roswell, Georgia 30075

## Re: K222294

Trade/Device Name: Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: July 30, 2022 Received: August 1, 2022

Dear Wava Truscott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

### K22294

Device Name

Black Nitrile Powder Free Patient Examination Glove. Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid

#### Indications for Use (Describe)

ASTM D6978-05 (2019) 7

This Nitrile patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner, and has also been Tested for Use with the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid.

| Test Results: | Chemotherapy Drug | Concentration | Minimum Time<br>Breakthrough |
|---------------|----------------------------------|-----------------------|------------------------------|
| | Carboplatin | 10 mg/mL | >240 min. |
| | Carmustine | 3.3 mg/mL | 32.5 min. |
| | Cisplatin | 1 mg/mL | >240 min. |
| | Cyclophosphamide | 20 mg/mL | >240 min. |
| | Dacarbazine | 10 mg/mL | >240 min. |
| | Docetaxel | 10 mg/mL | >240 min. |
| | Doxorubicin HCL | 2 mg/mL | >240 min. |
| | Etoposide | 20 mg/mL | >240 min. |
| | Fluorouracil | 50 mg/mL | >240 min. |
| | Gemcitabine | 38 mg/mL | >240 min. |
| | Ifosfamide | 50 mg/mL | >240 min. |
| | Paclitaxel | 6 mg/mL | >240 min. |
| | ThioTEPA | 10 mg/mL | 97.5 min. |
| | Vincristine Sulfate | 1 mg/mL | >240 min. |
| | Opioid & Gastric Acid | | |
| | Fentanyl citrate<br>(injectable) | 100mcg/2mL | >240 min. |
| | Gastric Acid (simulated) | 0.2% NaCl in 0.7% HCL | >240 min. |
| | Fentanyl in Gastric Acid | 50/50 mix | >240 min. |

CAUTION: Testing Showed a breakthrough time of 32.5 minutes for Carmustine and of 97.5 minutes for Thiotepa.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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